When the Kidney Reacts to Nutritional Changes

NCT04142138 | Completed

• 1 other identifier: DBI-1000
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension is one of the leading causes of morbidity and mortality in the industrialized world, attributed mostly to modifiable lifestyle factors. Aspects that are controlled by patients include physical activity, smoking, alcohol consumption, and nutrition. The DASH (Dietary Approach to Stop Hypertension) diet is a proven effective intervention in lowering blood pressure in multiple populations. In this proof of concept study, volunteers with untreated stage 1 hypertension, defined as mild high blood pressure with numbers in the range of 130 - 139 over 80 - 89, will receive a DASH-based menu during 5 days of hospitalization, during a weekend at home where they will continue the menu, another 5 days as inpatients, followed by a weekend at home on the same menu, and the return to the inpatient unit for an additional day for final testing. Throughout the intervention period, participants will be followed clinically and undergo repeated laboratory testing. The aim of this project is to characterize changes in urine electrolytes and exosome protein abundance pattern during nutritional changes, shifting from a "westernized diet" to a DASH diet.

Conditions

Prehypertension

Keywords

inpatient; nutrition

Outcome Measures

Primary Outcomes (3)

• urine exosome protein abundance pattern

  Mass spectrometry generates a list of proteins for each sample. We will compare fold of change before (Day 1) and after intervention (Day 12) - a true change is defined as 1.5 fold.

  Day 1 and Day 12

• urine electrolyte ratio in a spot urine as a surrogate to 24-h urine collection to assess nutritional consumption.

  spot urine will be analyzed for sodium and potassium parallel to 24-h urine collection. We will assess the concordance between the 24-h collection and the spot urine ratio of electrolytes. The result will be presented as a ratio of SPOT ratio (sodium/potassium) to 24-h collection ratio (sodium/potassium), for each participant. We will assess how close the ratio of ratios is to one.

  day 1,2,3,4,5,6,8,9,10,11,12,14

• 24-h urine collection as a measure of adherence to the DASH diet

  Urine will be collected throughout 24 hours to analyze electrolyte content, during intervention - twice, at the beginning (day 1) and end of intervention (day 12). We will be measuring daily sodium excretion, the threshold for compliance will be equal to or less than 100MEQ/d. For potassium daily excretion the threshold will be greater than or equal to 90meq/d . The change will be reported as number of participants that have met the defined threshold for compliance.

  day 1, 12

Study Arms (1)

nutrition implementation

EXPERIMENTAL

Volunteers with prehypertension, but otherwise healthy, will complete a screening visit, then be admitted to the In-Patient Unit for fourteen (14) days. Participants will be admitted for 5 days during the week and then go on pass for 2 weekend days each week with packed DASH diet meals. During hospitalization we will: 1) collect samples of blood and urine daily 2) monitor blood pressure, weight and pulse twice daily 3) collect 24-hour urine, twice during the period of two weeks 4) serve participants a menu based on DASH principles, namely low in sodium and high in potassium.

Other: DASH

Interventions

DASH OTHER

DASH diet is based on low salt, high potassium components, and is comprised of mainly fruits and vegetables. During hospitalization we will collect laboratory data of blood and urine, and follow participants clinically by measuring blood pressure.

nutrition implementation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• any gender, 18-60 years of age
• self described as White or Black individuals
• prehypertensives (=stage 1 hypertension) defined as sustolic blood pressure of 130-159 mmHG and/or diastolic blood pressure between 80-100.
• adequate dentition to consume fruits and vegetables as described for DASH -

You may not qualify if:

• Preexisting kidney disease structural or parenchymal including APCKD (adult polycystic kidney disease), single kidney (as assessed by ultrasound including size differences \>3 cm in diameter between kidneys), or evidence of RAS (renal artery stenosis)
• Pregnant
• HIV
• taking medications for diabetes, hyperlipidemia, cardiac disease, Medications for birth control, psychiatirc conditions, and sleep are Ok. Vitamins and herbs are Ok if continued throughout the study. Thyroid meds are acceptable if the TSH is within normal limits.
• Diabetes as defined by hemoglobin A1c \> 6.5% and/or fasting glucose \> 125 mg/dl
• Hyperlipidemia as defined by triglycerides \>200 and/or LDL \> 150
• Hematuria on screening
• RAAS (Renin-Angiotensin-Aldosterone) axis deviation - Aldosterone and Renin should be within normal ranges upon screening.
• BUN \> 40mg/dL corrected to body surface area
• Creatinine \> 1.3 mg/dL corrected to body surface area
• BMI \> 29.9 or \< 19
• Current smoker
• Currently, a vegetarian (who does not consume fish and dairy) or a vegan
• Based on medical history, any evidence of an autoimmune disease
• Use of any of the following - ACEi, ARB, spironolactone, diuretics of any class, beta blockers, alpha blockers, nsaids, within the past two weeks

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dana Bielopolski, MD PhD

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study assesses how nutritional changes, namely DASH diet, change the composition of ion channels in the renal tubule, as exemplified by urine electrolyte ratio.

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: February 22, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)